Charlie, Charlie , Charlie
St. Jude releases a PPR that stresses no problems whatsoever with Durata. hmmm. (from the website):
"The performance results for the combined Optim lead registries, for data collected through Feb. 29, 2012, include:
-- No instances of externalized conductors caused by inside-out abrasion
-- 99.96 percent rate of freedom from all-cause insulation abrasion
-- 99.84 percent rate of freedom from all-cause mechanical failure
"The performance data from the combined registries confirm that the Durata lead performs, at five years, as well as or better than other ICD leads on the market," said Dr. Charles Love, Professor of Medicine and Director of Cardiac Rhythm Device Services, Wexner Medical Center at The Ohio State University. "These data demonstrate that the changes in design and addition of Optim insulation material on St. Jude Medical's current-generation leads have significantly reduced the abrasion-related issues associated with Riata silicone-only leads."
St. Jude Medical also announced today that the largest of the three registries, the OPTIMUM registry, will be enhanced to further extend the study's follow-up duration to follow patients indefinitely. In addition, the registry protocol is currently in the process of implementing plans to collect fluoroscopic images of these leads going forward. This expanded protocol will provide additional insight into the performance of our current-generation leads.
"Our bi-annual product performance report is part of our commitment to providing physicians complete and accurate information so they can make decisions about how to best treat their patients," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "The combined registry data on our Optim leads represent the most robust post-market surveillance monitoring system in the ICD industry, which will also be independently verified by a third-party research institution. We are committed to ensuring that we deliver the highest quality devices possible."